Trial Outcomes & Findings for Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks (NCT NCT00986921)

Results Overview

Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.

Results posted on

2014-01-31

Participant Flow

Patients were recruited from the abortion clinic, after they had already consented to the abortion procedure, October 2009 to March 2011.

All women enrolled were assigned to groups. Group assignment was done very shortly after enrollment.

Participant milestones

Participant milestones
Measure	Standard Osmotic Dilator Insertion Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique.	Mifepristone Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique.
Overall Study STARTED	25	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Osmotic Dilator Insertion Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique.	Mifepristone Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique.
Overall Study Physician Decision	1	0

Baseline Characteristics

Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Osmotic Dilators n=25 Participants Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.	Mifepristone n=25 Participants Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25 years STANDARD_DEVIATION 6 • n=5 Participants	24 years STANDARD_DEVIATION 5 • n=7 Participants	25 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.

Population: Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.

Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)

Outcome measures

Outcome measures
Measure	Standard Osmotic Dilators n=24 Participants Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.	Mifepristone n=25 Participants Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used. Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.
Time for Completion of Procedure	8.0 Minutes Interval 6.75 to 11.47	9.87 Minutes Interval 8.93 to 11.36

SECONDARY outcome

Timeframe: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.

Population: All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated "easy or very easy" is tabulated

The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult".

Outcome measures

Outcome measures
Measure	Standard Osmotic Dilators n=24 Participants Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.	Mifepristone n=25 Participants Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used. Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.
Assessment of Ease of Procedure by Operator	46 percentage of participants	36 percentage of participants

SECONDARY outcome

Timeframe: Overnight

Population: All participants are included

Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)

Outcome measures

Outcome measures
Measure	Standard Osmotic Dilators n=25 Participants Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.	Mifepristone n=25 Participants Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used. Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.
Moderate or Severe Pain Overnight	52 percentage of participants	8 percentage of participants

Adverse Events

Standard Osmotic Dilators

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mifepristone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

Boston University Department of Obstetrics and Gynecology

Phone: 617-414-5175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place